The INFUSE - Anterior Myocardial Infarction (AMI) Study
- Conditions
- Acute Anterior Myocardial Infarction
- Interventions
- Registration Number
- NCT00976521
- Lead Sponsor
- Atrium Medical Corporation
- Brief Summary
This is a multicenter, open-label, controlled, single-blind, randomized study with up to 452 subjects enrolled in up to 50 US and European sites. Subjects who present with anterior ST-elevation myocardial infarction (STEMI) and an occluded proximal or mid left anterior descending (LAD) with TIMI 0/1/2 flow will be eligible for randomization to one of the following arms:
1. Local infusion of abciximab following thrombus aspiration
2. Local infusion of abciximab and no thrombus aspiration
3. No local infusion and thrombus aspiration
4. No local infusion and no thrombus aspiration
In addition, a cardiac magnetic resonance imaging (MRI) sub-study evaluating microvascular obstruction (MVO) will be performed with up to 160 subjects at up to 20 sites.
- Detailed Description
The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary infusion of an abciximab bolus with or without thrombus aspiration prior to stent implantation, compared to no infusion with or without thrombus aspiration (standard of care), results in 1) reduced infarct size measured by cardiac MRI at 30 days (range -7 days/+14 days; i.e., between 23 and 44 days), 2) reduce microvascular obstruction (MVO) by cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days), 3) enhanced ST-segment resolution, 4) improved myocardial perfusion, 5) reduced thrombus burden and angiographic complications, and 6) no increase in major and minor bleeding.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 452
- The subject must be >18 years of age;
- Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin;
- Anterior MI with ECG showing at least 1 mm of ST-segment elevation in 2 or more contiguous leads in V1-V4, or new (or presumably new) left bundle branch block;
- Anticipated symptom onset to balloon or aspiration time of ≤5 hours;
- The subject and his/her physician are willing to comply with specified follow-up evaluations;
- The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided and signed written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB)
- Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1/2 flow at the time of initial diagnostic angiography (prior to wire passage);
- Based on coronary anatomy, PCI is indicated for revascularization;
- Only one epicardial coronary artery will be treated;
- Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification).
Key
- Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction <40% by any prior measure or regional wall motion abnormalities);
- An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
- Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
- Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
- Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
- Any contraindication to undergo MRI imaging.
- Multivessel intervention required during the index procedure (subjects may be enrolled if treatment of more than one lesion in the LAD or its branches is required, however) (planned staged procedures are permitted with strong recommendation to be performed after 30-day clinical and MRI endpoints are completed);
- Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export® Aspiration Catheter;
- Features are present highly unfavorable for PCI;
- Target lesion is present within a bypass graft conduit;
- MI is due to thrombosis within or adjacent to a previously implanted stent;
- Left ventriculography demonstrates severe mitral regurgitation or a VSD;
- Unprotected left main stenosis >40% or that will require intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Local infusion, no aspiration Abciximab local infusion Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no aspiration No local infusion, no aspiration No local infusion No local infusion abciximab and no thrombus aspiration Local infusion, thrombus aspiration Abciximab local infusion Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration. Local infusion, thrombus aspiration Thrombus aspiration Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration. No local infusion, thrombus aspiration No local infusion No local infusion of abciximab, thrombus aspiration. No local infusion, thrombus aspiration Thrombus aspiration No local infusion of abciximab, thrombus aspiration.
- Primary Outcome Measures
Name Time Method Primary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Abciximab Infusion vs. No Infusion 30 Days Post Index Procedure The primary endpoint of the INFUSE AMI study is infarct size as a percentage of total left ventricular mass at 30 days as measured by cardiac MRI (cMRI), comparing the pooled randomized active (abciximab) infusion to the pooled non infusion arms, without regard to aspiration.
- Secondary Outcome Measures
Name Time Method Major Secondary Endpoint - Infarct Size at 30 Days as a Percentage of Total Left Ventricular Mass - Aspiration vs. No Aspiration 30 Days The major secondary endpoint of the INFUSE AMI Study is infarct size as a percentage of total myocardial mass at 30 days measured by cardiac MRI (cMRI), comparing the pooled randomized aspiration arms to the pooled no aspiration arms, without regard to abciximab infusion.
Trial Locations
- Locations (38)
Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Centrum Interwencyjne Leczenia Chorób Serca i Naczyń
🇵🇱Kraków, Poland
Bristol Heart Institute
🇬🇧Bristol, United Kingdom
Washington Adventist Hospital
🇺🇸Takoma Park, Maryland, United States
Carolinas Medical Center-SHVI
🇺🇸Charlotte, North Carolina, United States
Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Sentara Virginia Beach General Hospital
🇺🇸Virginia Beach, Virginia, United States
Landeskrankenhaus Braunau/Simbach
🇦🇹Braunau, Austria
Landeskrankenhaus Bruck/Mur
🇦🇹Bruck/Mur, Austria
Landeskrankenhaus Graz West
🇦🇹Graz, Austria
Univ. Klinik für Innere Medizin III Innsbruck
🇦🇹Innsbruck, Austria
Univ. Klinik für Innere Medizin II
🇦🇹Vienna, Austria
Facharzt fur Innere Medizin/Kardiologie
🇩🇪Ludwigshafen, Germany
Klinikum Villingen Kardiologie
🇩🇪Darmstadt, Germany
Charite- University Medicine Campus Benjamin Franklin
🇩🇪Berlin, Germany
Klinikum der Universität Regensburg
🇩🇪Regensburg, Germany
Polsko - Amerykańskie Kliniki Serca II Oddział Kardiologiczny American Heart of Poland Sp. z o.o.
🇵🇱Bielsko-Biała, Poland
Universtitätsklinikuim Ulm
🇩🇪Ulm, Germany
Ziekenhuis Rijnstate
🇳🇱Arnhem, NL, Netherlands
Catharina Hospital Eindhoven
🇳🇱Eindhoven, Netherlands
Isala Klinieken, Locatie de Weezenlanden
🇳🇱Zwolle, Netherlands
Pracownia Hemodynamiki Oddziału Kardiologicznego Wojewódzkiego Centrum Medycyny w Opolu
🇵🇱Opole, Poland
SPZOZ Szpital Uniwersytecki w Krakowie, Samodzielna Pracownia Hemodynamiki i Angiografii
🇵🇱Kraków, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie Pracownia Hemodynamiki I Katedry i Kliniki Kardiologii
🇵🇱Warszawa, Poland
Instytut Kardiologii im. Prymasa Tysiąclecia Kardynała Stefana Wyszyńskiego,I Samodzielna Pracownia Hemodynamiki
🇵🇱Warszawa, Poland
King's College Hospital
🇬🇧London, U.k., United Kingdom
University Hospitals of Leicester - Glenfield Hospital
🇬🇧Leicester, U.k., United Kingdom
Southampton University Hospital
🇬🇧Southampton, U.k., United Kingdom
Royal Victoria Hospital, Belfast Trust
🇬🇧Belfast, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, U.k., United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, U.k., United Kingdom
Freeman Hospital
🇬🇧Newcastle-upon-Tyne, United Kingdom
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Moses Cone Vascular Center
🇺🇸Greensboro, North Carolina, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Harrisburg Hospital/ Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
Universitätsmedizin Mannheim - I. Medizinische Klinik
🇩🇪Mannheim, Germany
Centrum Kardiologii Inwazyjnej GVM Carint
🇵🇱Oswiecim, Poland
Krakowskie Centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii
🇵🇱Krakow, Poland